Newborn whole-genome sequencing and genetic disease risk in pregnancy and early life
Accurate Assessment and Intervention Research on Newborn Whole Genome Sequencing and Genetic Disease Risk(China Baby Omics)
This project will collect small biological samples from pregnant families and newborns to try whole-genome sequencing and other multi-omics tests to find genetic disease risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000000 (estimated) |
| Sex | All |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07365254 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll families during pregnancy or with newborn infants, obtain informed consent, and collect questionnaires and small biological samples at specified times. Samples may include peripheral blood, urine, and vaginal secretions and will undergo multi-omics processing such as nucleic acid extraction, sequencing, proteomics, metabolomics, and microbiome analysis. Generated genomic and other omics data will be stored in the hospital database and made available to approved investigators under review procedures. The project is an observational cohort designed to link genetic, environmental, and clinical data to maternal and child health outcomes.
Who should consider this trial
Good fit: Ideal candidates are families with ongoing pregnancies (natural or assisted conception) or newborn infants who are willing to provide consent, complete questionnaires, and give small biological samples at the participating hospital.
Not a fit: People who are not pregnant, do not have a newborn, are unwilling to consent or provide samples, or who need immediate therapeutic treatment are unlikely to benefit directly from this observational project.
Why it matters
Potential benefit: If successful, this could enable earlier identification of genetic risks in newborns and inform follow-up monitoring or early interventions.
How similar studies have performed: Similar cohort and newborn genomic sequencing projects internationally have demonstrated feasibility and diagnostic yield for some conditions, but large-scale clinical impact and implementation pathways are still being established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Families with ongoing pregnancies (via assisted reproductive therap or natural conception) and newborn infants. Exclusion Criteria: * None
Where this trial is running
Hangzhou, Zhejiang
- Women's Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Hengchao Ruan, phD
- Email: ruanhengchao@zju.edu.cn
- Phone: 0571-88208964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.